FDA Medical devices recall ·
IontoPatch 80, On-the-Go Patch Therapy, Model recall
- Recall number
- Z-2197-2025
- Date
- (initiated May 22, 2025)
- Company / brand
- LTS Therapy Systems, LLC
1685 Marthaler Ln, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 63936 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
Why was it recalled?
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3
Distribution
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
States: Illinois Indiana Kentucky Minnesota New Jersey New York Ohio South Dakota Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2197-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.